Product Development

Having a great idea is one thing. Building a product is another. Let us help.

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Our process

Discover how we've helped clients worldwide

01

Ideate

Understanding your invention and business goals.

02

Prototyping

Building early prototypes to build your IP portfolio.

03

IP Development

Filing patents and securing intellectual property.

04

Small Scale Manufacture

Developing manufacturing g capability to build your product.

Concept Development Services

Concept development is the structured process of refining ideas into clear, feasible concepts that define purpose and features for visualisation. At Innovate Medtech, we deliver this process for you

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Mechanical Design

  • Decades of mechanical design expertise from experienced in-house engineers.
  • Engineers collaborate closely with clients to refine concepts with precision and detail.
  • Full integration of in-house prototyping capabilities for rapid transformation of ideas into functional models.
  • Iterative development process ensures each product meets customer needs.
  • Prototyping and engineering workflow help mitigate design risks and validate concepts early.
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Industrial Design

  • Industrial design is the foundation for turning ideas into real products.
  • Innovate Medtech manages the product journey from concept through to completion.
  • Deliverables include detailed designs, high-quality renders, and functional prototypes.
  • Decades of industrial design experience underpin expert consulting services.
  • In-house expertise covers intellectual property, product design, and regulatory compliance.
  • Ensure your product meets your needs and is prepared for progression to the next development stage.
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End to End Medical Device Design & Development

Complete product development from concept to commercial launch.

What we delive:

  • Identification of user needs and translation into design requirements
  • Industrial design, mechanical/electrical engineering, and systems integration
  • Prototyping, verification, validation, and design for manufacture (DFM)
  • Quality management and regulatory compliance (ISO 13485, FDA, TGA, EU MDR/IVDR)
  • Support through pilot manufacturing, clinical evaluation, and market entry
Outcome: A seamless, integrated pathway to take your medical device idea from concept through to reality.

Quality & Regulatory

Practical, stage-appropriate regulatory and quality support for medtech innovators.

What we delive:

  • Regulatory strategy, gap analysis, and pathway definition across FDA, TGA, and EU MDR/IVDR
  • Preparation and management of submissions, including 510(k), De Novo, PMA, CE Marking
  • FDA and notified body interactions, including breakthrough device designation support
  • ISO 13485-compliant product development with risk management (ISO 14971)
  • Design and implementation of fit-for-purpose QMS, from lean start-up systems to full-scale compliance
Outcome: Confidence that your device meets global regulatory expectations while building a scalable quality foundation.
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Get Started Today?

Partner with us to revolutionize the medtech industry and bring your ideas to life.
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Ready to take your ideas to impact?

Partner with us to revolutionize the medtech industry and bring your ideas to life.

Let's Talk

+61 403 341 183

michael@innovatesci.tech

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